This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
HonorHealth Research Institute
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
The Royal Marsden
Sutton, London, United Kingdom
Assess the safety and tolerability of VS-5584 in subjects with advanced non-hematologic malignancies or lymphoma
Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety Monitoring Committee will review safety information.
Time frame: From start of treatment to end of treatment, an expected average of 6 weeks
Determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) and schedule of VS-5584 administered to subjects with advanced non-hematologic malignancies or lymphoma
The RP2D will be determined based on the MTD of VS-5584 as determined by number of participants with dose limiting toxicities related to VS-5584. Observations related to pharmacokinetics, pharmacodynamics, and any VS-5584 related toxicities may be included in the rationale supporting the RP2D and schedule and will not exceed the MTD.
Time frame: From start of treatment to end of Cycle 1 (21 day cycles)
Assess the pharmacokinetics of VS-5584
PK (pharmacokinetics) parameters, including but not limited to plasma concentration, clearance, AUC (Area Under Curve, 0-24 and 0-t), Cmax, Tmax, and T1/2
Time frame: Time points on Day 1, 2, 3, 17, 18
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